氧化樟脑原料药及注射液国家药品标准提高工作概述  

An Overview of Improvement of National Drug Standards of Vitacamphorae and Its Injection

作　　者：岳志华[1] 刘孟斯 兰奋[1] YUE Zhihua;LIU Mengsi;LAN Fen(Chinese Pharmacopoeia Commission,Beijing 100061;Center for Drug Evaluation of National Medical Products Administration,Beijing 100022)

机构地区：[1]国家药典委员会,北京100061 [2]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国医药工业杂志》2021年第3期386-389,共4页Chinese Journal of Pharmaceuticals

摘　　要：为更好地控制药品质量,对氧化樟脑原料药及注射液开展了国家药品标准提高的工作。本文重点针对氧化樟脑及其注射液国家药品标准中有关物质检查方法的修订和提高过程进行了分析,阐明了氧化樟脑原料药及注射液国家药品标准提高工作的思路和过程。试验结果表明,提高后的国家药品标准可以有效控制氧化樟脑原料药及其注射液的降解产物及其他杂质,提高了产品的质量可控性和安全性,为制定相关国家药品标准提供了参考。In order to control the quality of medicines preferably,the national drug standards of vitacamphorae and its injection were improved.This study focused on the analysis of the revision and improvement process of the inspection methods of related substances,and clarified the thinking and process of the standard improvement.The results showed that the improved national drug standards could effectively control the degradation products and other impurities of vitacamphorae and its injection,and the quality controllability and safety of the products were improved,which provided a reference for formulating relevant national drug standards.

关 键 词：氧化樟脑 氧化樟脑注射液 国家药品标准提高 质量控制 

分 类 号：R95[医药卫生—药学] R926